MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P50 MULTIPACK; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515106
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Foreign matter found in keytruda bag.Event details: it was reported that two vials of keytruda were prepared, the liquid was collected from each vial and infused into the infusion bag.Before the infusion bag was handed over to the nurse, the person in charge checked the bag and found foreign matter.One particle was found by visual inspection.Please analyze the size of the core.(it is mixed in the bag.) the lot of the injector is unknown.The incident occurred after connecting the protector and injector.The product that was connected to the infusion bag was 515309.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: it was reported that particles were observed inside an iv bag.For investigation, two vials, one iv bag, one l-connector, and a device not manufactured by bd were provided to the quality team.Upon inspection, a gray particle was confirmed inside the infusion bag.Testing determined that the particle was consistent with material from the infusion bag's rubber stopper.No damage or defects were identified within our device that could have contributed to this observation.Additionally, particles were noted within the vial itself, which also appear to be consistent with material from the vial stopper.Coring of a rubber stopper can occur depending on stopper quality, stopper design, or if an incomplete or misaligned connection is made during spiking.Finished products for this reference undergo sampling as well as visual and functional inspections throughout the various manufacturing subprocesses in accordance with established procedures.Because a lot number was not provided for this incident, a device history record review could not be completed.Based on the available information, we cannot definitively determine which spike was responsible for introducing the particle observed in the iv bag; therefore, a root cause cannot be established at this time.The quality team will continue to monitor complaints for this device and reported condition for any emerging trends.
Event or Problem Description
No additional information.

• Brand Name: PROTECTOR P50 MULTIPACK
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22329090
• Report Number: 3003152976-2025-00314
• Device Sequence Number: 13132242
• Product Code: ONB
• UDI-Device Identifier: 00382905151064
• UDI-Public: (01)00382905151064
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 515106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown